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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAK Liquid Acrylic Resin

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 Class 2 Device Recall IMPAK Liquid Acrylic Resinsee related information
Date Initiated by FirmNovember 18, 2013
Date PostedMarch 09, 2016
Recall Status1 Terminated 3 on May 23, 2018
Recall NumberZ-1089-2016
Recall Event ID 71148
510(K)NumberK033020 
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
ProductIMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
Code Information Lot Number 103113
FEI Number 1315551
Recalling Firm/
Manufacturer		 CMP Industries, Llc
413 N Pearl St
Albany NY 12207-1311
For Additional Information ContactJohn Nicpon
518-434-3147
Manufacturer Reason
for Recall		During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn November 18, 2013, CMP Customer Service contacted customers by telephone requesting return of the affected product and customers were issued a UPS Call Tag. CMP issued a letter to non-responding customers dated December 9, 2013, requesting return of the product because of the possibility of foreign particles. The letter states, the firm found that one of their processes could deliver a material that would pass their QC tests, but may introduce foreign material into the liquid. A customer service representative will be in contact with customers to arrange the return of the product.
Quantity in Commerce246 units
DistributionWorldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EBI
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